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FDA 510(k) Application Details - K070056
Device Classification Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
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510(K) Number
K070056
Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant
VAPOTHERM, INC.
555 THIRTEENTH STREET, NW
WASHINGTON, DC 21666 US
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Contact
JOHNATHAN KAHAN
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Regulation Number
868.5450
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Classification Product Code
BTT
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More FDA Info for this Product Code
Date Received
01/05/2007
Decision Date
04/13/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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